Colorectal CancerNCT06136026
Integrated Chinese and Western Medicine Specialized Disease Cohort for Colorectal Cancer
An observational study of Colorectal Cancer and Colorectal Adenoma, run by Jiangsu Famous Medical Technology Co., Ltd..
Trial summary
This is a nationwide cohort study on integrated traditional Chinese and Western medicine for colorectal cancer. The aim is to elucidate the distribution patterns of TCM syndromes in colorectal cancer and colorectal adenoma, reveal the relationship between TCM syndromes and diagnosis, prognosis, and prognosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Colorectal Adenoma
- How many people
- 50,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 31 Dec 2033
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diagnostic criteria for CRC: refer to the diagnostic criteria in the 2023 Chinese Guidelines for Integrated Diagnosis and Treatment of Malignant Tumors - Colon Cancer Part. Diagnostic criteria for colorectal adenoma: Refer to the Western diagnostic criteria for colorectal adenoma in the Pathological Diagnosis Consensus of Gastrointestinal adenoma and Benign epithelial polyps published by the Digestive Diseases Group of the Pathology Society of the Chinese Medical Association.
Who may be able to join
- CRC patients:
- The patient is over 18 years old;
- The patient meets the diagnostic criteria for colorectal cancer;
- The patient has not received anti-tumor treatment such as surgery, chemotherapy, radiotherapy, targeted therapy, or immunity in the past;
- The patient voluntarily participated in this study and signed an informed consent form.
- Colorectal adenoma patients
Show all 9Show fewer
- The patient is over 18 years old;
- The patient meets the diagnostic criteria for colorectal adenoma;
- The patient voluntarily participated in this study and signed an informed consent form.
Who cannot join
- CRC patients:
- Combined with other malignant tumors;
- The patient has severe cognitive impairment, dementia, and various mental disorders.
- Colorectal adenoma patients:
- The patient had a history of malignancy;
- The patient has severe cognitive impairment, dementia, and various mental disorders.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Integrative Chinese and Western Medicine for Colorectal Cancer: A Nationwide Prospective Cohort Study
This is a nationwide cohort study on integrated traditional Chinese and Western medicine for colorectal cancer. The aim is to elucidate the distribution patterns of TCM syndromes in colorectal cancer and colorectal adenoma, reveal the relationship between TCM syndromes and diagnosis, prognosis, and prognosis. Based on biological samples, a phenotypic omics study of TCM syndromes in colorectal cancer and colorectal adenoma is conducted.
Read the detailed description
Colorectal cancer (CRC) is a common malignant tumor. The global cancer data in 2020 shows that the incidence rate of CRC ranks the third in the world, and the mortality rate ranks the second in the world. China is a large country of CRC. In 2016, China's incidence rate of CRC ranked second in malignant tumors, and its mortality ranked fourth. Both incidence rate and mortality are on the rise. At present, studies have shown that TCM plays an important role in the prevention and treatment of precancerous lesions, recurrence, and metastasis of CRC throughout the entire process. However, the clinical efficacy and mechanism of TCM intervention in the onset, progression, and metastasis of CRC still need further research evidence to support. This project aims to address the above issues, based on the advantages of TCM in tumor prevention and treatment, and actively construct the first large-scale integrated traditional Chinese and Western medicine CRC specialized disease queue in China. The study focuses on the key links of the "precancerous lesions, recurrence, and metastasis" progress of CRC and conducts a combination of disease and syndrome queue research. The project is based on the team's preliminary research results and collaborates with multiple regional diagnosis and treatment centers in China to form high-quality evidence-based medical evidence and unify TCM syndrome differentiation standards for CRC. At the same time, based on the study of specialized disease cohorts, the project breaks through the phenotype omics of TCM, further revealing the biological connotation of TCM syndromes in colorectal cancer, achieving the integration of Chinese and Western medicine, breaking through the bottleneck of basic research on CRC in TCM, assisting the research process of traditional Chinese medicine in preventing and treating CRC, and promoting the modernization of TCM.
- Conditions
- Colorectal Cancer, Colorectal Adenoma
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Rectal cancer cohort | 20,000 patients with rectal cancer will be included in this cohort and followed for five years. | |
| Colon cancer cohort | 20,000 patients with colon cancer will be included in this cohort and followed for five years. | |
| Colorectal adenoma cohort | 10,000 patients with colorectal adenomas will be enrolled in this cohort and followed for five years. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival of patients with CRC
Patients were recorded from the time they entered the study until their final death.
Measured: 5 years
The detection rate of Colorectal Adenomatous Polyp.
In the follow-up plan, record the proportion of patients diagnosed with colorectal adenoma after colonoscopy examination.
Measured: 5 years
Secondary outcomes (6)
Quality of life of CRC patients
The quality of life will be evaluated using the KPS score. The higher the KPS score, the better the patient's health condition.
Measured: 5 years
Recurrence rate of CRC patients
Record the number of patients with recurrence at each time point.
Measured: 5 years
Metastasis rate of CRC patients
Record the number of patients with metastasis at each time point.
Measured: 5 years
Disease-free survival (DFS) of CRC patients
The evaluation criteria for DFS are as follows: after radical treatment, the patient has reached a disease-free state or complete remission, and after this, the time span until the first assessment of tumor recurrence or metastasis or death without recurrence or metastasis, the patient is in a tumor free state at this stage.
Measured: 5 years
Progression-free survival (PFS) of CRC patients
The evaluation criteria for PFS are as follows: the time span from the start of tumor treatment upon patient enrollment to the first assessment of disease progression or death without progression, during which the tumor has basically not progressed.
Measured: 5 years
The canceration rate of Colorectal Adenomatous Polyp.
In the follow-up plan, record the proportion of patients diagnosed with colorectal cancer after colonoscopy examination.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Dec 2023 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Famous Medical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Jiangsu Province Hospital of Traditional Chinese Medicine, Peking University Cancer Hospital & Institute, Fujian Cancer Hospital, Hubei Cancer Hospital, Shandong Cancer Hospital and Institute, Shanxi Province Cancer Hospital, Sichuan Cancer Hospital and Research Institute, Yunnan Cancer Hospital, Zhejiang Cancer Hospital, Xiangya Hospital of Central South University, Chongqing University Cancer Hospital, The First Affiliated Hospital of Anhui Medical University, First Affiliated Hospital of Guangxi Medical University, First Affiliated Hospital of Harbin Medical University, Guangdong Provincial Hospital of Traditional Chinese Medicine, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Tianjin Medical University Cancer Institute and Hospital, Gansu Cancer Hospital
- Responsible party
- Sponsor
- Investigators
- Hai bo Cheng, Professor, Study chair, Affiliated Hospital of Nanjing University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06136026
- Sponsor's protocol ID
- ZLXTCXZX-2023001
- Status last verified
- Nov 2023
- First submitted
- 6 Nov 2023
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hui YF, Song SC, Zhu WJ, Bu S, Sun J, Ling TS, Cheng HB. Multicenter prospective cohort study on colorectal adenoma recurrence and malignant transformation risk based on integrative medicine: a study protocol. Front Oncol. 2025 Oct 27;15:1657390. doi: 10.3389/fonc.2025.1657390. eCollection 2025.
PubMed 41220937
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Chinese and Western Medicine for Colorectal Cancer: A Nationwide Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06136026
- Acronym / sponsor ID
- ZLXTCXZX-2023001
- Conditions
- Colorectal Cancer, Colorectal Adenoma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- Jiangsu Famous Medical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Jiangsu Province Hospital of Traditional Chinese Medicine, Peking University Cancer Hospital & Institute, Fujian Cancer Hospital, Hubei Cancer Hospital, Shandong Cancer Hospital and Institute, Shanxi Province Cancer Hospital, Sichuan Cancer Hospital and Research Institute, Yunnan Cancer Hospital, Zhejiang Cancer Hospital, Xiangya Hospital of Central South University, Chongqing University Cancer Hospital, The First Affiliated Hospital of Anhui Medical University, First Affiliated Hospital of Guangxi Medical University, First Affiliated Hospital of Harbin Medical University, Guangdong Provincial Hospital of Traditional Chinese Medicine, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Tianjin Medical University Cancer Institute and Hospital, Gansu Cancer Hospital
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2033 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a nationwide cohort study on integrated traditional Chinese and Western medicine for colorectal cancer. The aim is to elucidate the distribution patterns of TCM syndromes in colorectal cancer and colorectal adenoma, reveal the relationship between TCM syndromes and diagnosis, prognosis, and prognosis. Based on biological samples, a phenotypic omics study of TCM syndromes in colorectal cancer and colorectal adenoma is conducted.
Detailed description
Colorectal cancer (CRC) is a common malignant tumor. The global cancer data in 2020 shows that the incidence rate of CRC ranks the third in the world, and the mortality rate ranks the second in the world. China is a large country of CRC. In 2016, China's incidence rate of CRC ranked second in malignant tumors, and its mortality ranked fourth. Both incidence rate and mortality are on the rise. At present, studies have shown that TCM plays an important role in the prevention and treatment of precancerous lesions, recurrence, and metastasis of CRC throughout the entire process. However, the clinical efficacy and mechanism of TCM intervention in the onset, progression, and metastasis of CRC still need further research evidence to support. This project aims to address the above issues, based on the advantages of TCM in tumor prevention and treatment, and actively construct the first large-scale integrated traditional Chinese and Western medicine CRC specialized disease queue in China. The study focuses on the key links of the "precancerous lesions, recurrence, and metastasis" progress of CRC and conducts a combination of disease and syndrome queue research. The project is based on the team's preliminary research results and collaborates with multiple regional diagnosis and treatment centers in China to form high-quality evidence-based medical evidence and unify TCM syndrome differentiation standards for CRC. At the same time, based on the study of specialized disease cohorts, the project breaks through the phenotype omics of TCM, further revealing the biological connotation of TCM syndromes in colorectal cancer, achieving the integration of Chinese and Western medicine, breaking through the bottleneck of basic research on CRC in TCM, assisting the research process of traditional Chinese medicine in preventing and treating CRC, and promoting the modernization of TCM.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Rectal cancer cohort | – | –20,000 patients with rectal cancer will be included in this cohort and followed for five years. |
| Colon cancer cohort | – | –20,000 patients with colon cancer will be included in this cohort and followed for five years. |
| Colorectal adenoma cohort | – | –10,000 patients with colorectal adenomas will be enrolled in this cohort and followed for five years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diagnostic criteria for CRC: refer to the diagnostic criteria in the 2023 Chinese Guidelines for Integrated Diagnosis and Treatment of Malignant Tumors - Colon Cancer Part. Diagnostic criteria for colorectal adenoma: Refer to the Western diagnostic criteria for colorectal adenoma in the Pathological Diagnosis Consensus of Gastrointestinal adenoma and Benign epithelial polyps published by the Digestive Diseases Group of the Pathology Society of the Chinese Medical Association.
Key inclusion criteria (9 listed)
- The patient is over 18 years old;
- The patient meets the diagnostic criteria for colorectal cancer;
- The patient has not received anti-tumor treatment such as surgery, chemotherapy, radiotherapy, targeted therapy, or immunity in the past;
- The patient voluntarily participated in this study and signed an informed consent form.
- Colorectal adenoma patients
Key exclusion criteria (6 listed)
- Combined with other malignant tumors;
- The patient has severe cognitive impairment, dementia, and various mental disorders.
- The patient had a history of malignancy;
- The patient has severe cognitive impairment, dementia, and various mental disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival of patients with CRC
Time frame: 5 years
Patients were recorded from the time they entered the study until their final death.
The detection rate of Colorectal Adenomatous Polyp.
Time frame: 5 years
In the follow-up plan, record the proportion of patients diagnosed with colorectal adenoma after colonoscopy examination.
6 secondary outcomes
Quality of life of CRC patients
Time frame: 5 years
Recurrence rate of CRC patients
Time frame: 5 years
Metastasis rate of CRC patients
Time frame: 5 years
Disease-free survival (DFS) of CRC patients
Time frame: 5 years
Progression-free survival (PFS) of CRC patients
Time frame: 5 years
The canceration rate of Colorectal Adenomatous Polyp.
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Derived from this study: PubMed 41220937Hui YF, Song SC, Zhu WJ, Bu S, Sun J, Ling TS, Cheng HB. Multicenter prospective cohort study on colorectal adenoma recurrence and malignant transformation risk based on integrative medicine: a study protocol. Front Oncol. 2025 Oct 27;15:1657390. doi: 10.3389/fonc.2025.1657390. eCollection 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hai bo Cheng, Professor study chair
Affiliated Hospital of Nanjing University of Chinese Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer and Colorectal Adenoma, run by Jiangsu Famous Medical Technology Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hai bo Cheng, Professor (025-85811001, hbcheng@njucm.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival of patients with CRC (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06136026, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.